Topic
Single-use and limited-use medical supplies.
A buyer specification guide to 21 CFR 868.6810 BSY airway suction catheters: ISO 8836:2019 open vs closed fields, French size, control vents, circuit adapters, and 510(k) exemption limits.
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Specify FDA Class II sharps containers as product code MMK under 21 CFR 880.5570, with OSHA 1910.1030 construction fields, labeled fill-line volume, and ISO 23907-1 or 23907-2—not a needle code.
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A technical procurement guide to evacuated venous blood collection tubes: 21 CFR 862.1675 GIM vs JKA codes, ISO 6710 container scope, draw volume tolerances, additive chemistry, and closure specifications.
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A buyer guide to 21 CFR 868.5730 tracheal tubes: ISO 5361 scope, labeled millimetre inside diameter, cuff and Murphy eye options, 15 mm ISO 5356-1 connectors, and FDA's 2026 transition.
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Match gauze, hydrophilic, occlusive, and hydrogel SKUs to 21 CFR 878 Class I codes versus unclassified FRO, MGQ, MGP, and KGN—without treatment protocols.
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A technical receiving guide to medical consumable UDI capture under 21 CFR 801, UPC-as-UDI rules, Class I PI exceptions, AccessGUDID verification, and dated enforcement discretion.
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A buyer specification guide to ISO 8537 insulin syringes: 21 CFR 880.5860 FMF codes, U-100 unit graduations, orange cap coding, and distinctions from ISO 7886-1 hypodermics.
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A buyer specification guide to FDA short-term (<30 days) versus long-term (≥30 days) intravascular catheters: 21 CFR 880.5200 vs 880.5970, product codes FOZ, PND, and LJS, ISO 10555 standards, and 510(k) evidence fields.
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A buyer specification guide to ISO 20696 intermittent urethral catheters under 21 CFR 876.5130: FDA product codes EZD and GBM, partial recognition Rec# 9-143, tip shapes, and coating data.
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How hospital and distributor receiving teams record visible sterile-pouch damage, packaging level, and labeled identity for supplier review without assuming sterility.
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A veterinary laboratory purchasing worksheet for comparing replacement cartridge or reagent SKUs to installed analyzers, separating labeled identity from missing manufacturer facts.
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A hospital buyer and distributor reconciliation guide for tracing mixed-lot consumables across packaging levels during a recall without mistaking a UDI-DI match for scope.
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