FDA.report

10M - Mallory - Metal

Primary DI
00766588170503
Brand
10M - Mallory - Metal
Company
Certified Safety Manufacturing, Inc.
Model
K617-050
Catalog number
K617-050
Device description
10M - Mallory - Metal
Published
2022-07-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
CBPValve, non-rebreathing

Product Code Classifications

CodeDeviceSpecialtyClass
CBPValve, Non-RebreathingAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00766588170503PrimaryGS10

Alternate GTIN/UPC/EAN values are derived from GS1 digit structure for lookup convenience. Do not treat derived UPC-A or EAN-13 values as separate FDA identifiers. GTIN-14 values with indicator digits 1-9 usually represent packaging levels, cases, pallets, or variable-measure items and are not converted to UPC-A/EAN-13 here.

Alternate GTIN / UPC / EAN Codes

Source identifierSource lengthGTIN-14 normalizedIndicatorUPC-AEAN-13Conversion note
00766588170503140076658817050307665881705030766588170503Indicator 0 and prefix 00 allow UPC-A and EAN-13 conversion.

GMDN Terms

TermDefinition
Dressing-fixation skin adhesive tape, non-siliconeA long and narrow flexible band of non-silicone-based material (e.g., fabric, plastic, paper) coated on one or both sides with a pressure-sensitive adhesive, intended to non-invasively adhere to the skin surface to fix a dressing in place or attach objects (e.g., catheter, lamp); it might have hypoallergenic and/or waterproof properties. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(816)483-9090Info@certifiedsafety.com

Regulatory Flags

DUNS number
788460483
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00766588252070Snake Bite EconomyR525-207R525-2072026-02-05
00766588252087PG&E Expirables - ZLBR525-208R525-2082026-02-05
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00766588250076Safety General Purpose - 10 Poly WhiteK625-007K625-0072025-12-18
00766588235745628 - Non-Stick Pads 2"x 3" - 4/unitR523-574R523-5742025-12-17
00766588120676RR - UP Facilities - 75VK612-067K612-0672025-12-15
00766588235721608 - Adhesive Bandages Plastic 2"x 3" - 6/unitR523-572R523-5722025-12-15
00766588160825816 - Nitrile Gloves - 2 pr/unitR216-082R216-0822025-12-08
00766588190051QF Tape 1/2" x 2.5 yds. - RollR519-005R519-0052025-12-08
00766588250083Safety General Purpose - 16 Poly WhiteK625-008K625-0082025-12-08
00766588069012Gillig Bus 24 - RefillKR606-301KR606-3012025-12-02
00766588042053New Mexico SBK - 24 Poly WhiteS204-205S204-2052025-08-21
00766588089560Mississippi BFK - RefillFKR208-056FKR208-0562025-08-21

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